It is sometimes necessary or desirable to secure a tissue or portion of a tissue within the body of an animal, such as a human. Sling devices are known in the art and can be used to affect such a securement of tissue within the body.
Obstructive Sleep Apnea (OSA) is a clinical disorder in which a partial or complete collapse of soft tissue occurs in the airway during sleep. This leads to a blockage of the airway and impaired breathing during sleep. Mild OSA can lead to fatigue, reduced alertness following sleep, and a general reduction in productivity for the affected individual. Severe OSA can lead to sleep deprivation, hypoxemia, and depression.
OSA can be the result of obesity and/or diabetes. It is believed that about 1 in every 15 Americans are affected by some form of OSA, leading to an estimated $3.4 billion in associated healthcare costs each year.
The art provides various options for the treatment of OSA. Continuous Positive Airway Pressure (CPAP) machines, which supply positive air pressure through a facemask and into the airway during sleep, are used most frequently. The positive air pressure maintains an open airway to prevent apnea and snoring. While these machines are generally considered effective, they are bulky, noisy, and cumbersome to use. Furthermore, use of these machines can be socially awkward for some individuals.
Oral appliances that force the jaw forward to maintain an open airway can also be used. These devices are generally considered to be not as effective as CPAP machines, and can be uncomfortable to use. Furthermore, these devices are frequently ejected from the mouth during sleep, reducing their effectiveness over the entire course of a sleeping period.
Invasive surgical procedures can also be used to treat OSA. Various techniques have been described, including uvulopalatopharyngoplasty (UPPP, maxillomandibular advancement (MMA), and even tracheostomy. Surgical procedures are generally considered to have limited and potentially short-lived effectiveness. Furthermore, many of the procedures require hospitalization and the use of general anesthesia. As a result, these procedures are generally reserved for severe cases of OSA.
The Repose™ System from Medtronic provides a surgical-based tongue suspension procedure that can be performed with or without an adjunct hyoid suspension procedure. These suspension procedures require a surgical incision and dissection of the neck below the mandible. Following implantation of one or more necessary bone screws, sutures are lashed around the tongue and/or hyoid bone and secured with surgical notes. While these procedures offer less complicated solutions than the more invasive surgical procedures above, they still require surgical intervention and suffer from the drawbacks associated with surgical procedures. Furthermore, over time, the sutures used to suspend the tongue and/or hyoid bone may weaken under constant stress and fracture or snap, which may limit the effectiveness of the treatment over time. Lastly, the use of sutures in these procedures necessitates the use of specialized knotting and securement techniques to complete the procedure, which adds an additional opportunity for error and failure in the device and the procedure.
Recent advancements in the art include the use of sling devices for securing the tongue, advancing it forward toward the chin of the patient, and permanently securing the tongue in this new position. These new devices and methods of treatment offer several distinct advantages, including the avoidance of invasive surgical procedures, the use of durable and well-characterized long-term implant materials, and a securement approach that provides long-term stability of the tongue in its new position following treatment.
Considering the advantages of these devices, a need exists for ancillary medical devices, kits, and methods that provide for their reliable and predictable placement.